FDA.reportPublic FDA data

Hokanson

Primary DI
00817065020849
Brand
Hokanson
Company
D.E.HOKANSON, INC.
Model
03759
Catalog number
03759
Device description
2.0 cm disposable digit vascular cuff-Quarter Turn Connector
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXQBlood Pressure Cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXQBlood Pressure CuffCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K932851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K932851000DISPOSABLE PENILE BLOOD PRESSURE CUFFSD. E. Hokanson, Inc.1993-11-15DXQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817065020856PackageGS110In Commercial Distribution
00817065020863PackageGS125In Commercial Distribution
00817065020870PackageGS1100In Commercial Distribution
00817065020849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817065020856008170650208568170650208560817065020856
00817065020863008170650208638170650208630817065020863
00817065020870008170650208708170650208700817065020870
00817065020849008170650208498170650208490817065020849

GMDN Terms#

Term, Definition table
TermDefinition
Blood pressure cuff, single-useA band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is typically wrapped around the upper arm of the patient. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width2Centimeter

Contacts#

Phone, Email table
PhoneEmail
800-999-8251info@deh-inc.com
425-882-1689info@deh-inc.com

Regulatory Flags#

DUNS number
071829634
Device count
1
Lot or batch
true
Manufacturing date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817065020153Hokanson03845038452026-03-27
00817065022614Hokanson03844038442026-03-27
00817065022621Hokanson03843038432026-03-27
00817065022638Hokanson03842038422026-03-27
00817065022645Hokanson03841038412026-03-27
00817065022652Hokanson03840038402026-03-27
00817065022348HokansonDP2.5™431012017-07-18
00817065022607Hokanson03027030272021-10-14
00817065022584Hokanson43305433052021-09-16
00817065022591Hokanson43306433062021-09-16
00817065022522Hokanson43660436602020-04-27
00817065022539Hokanson43662436622020-04-27
00817065022546Hokanson43664436642020-04-27
00817065022553Hokanson43666436662020-04-27
00817065022560Hokanson43668436682020-04-27
00817065022508HokansonDP2.0™037382019-06-14
00817065020061Hokanson03602036022016-09-09
00817065020085Hokanson03079030792016-09-09
00817065020139Hokanson03686036862016-09-09
00817065020214Hokanson03632036322016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06931973454689CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456737CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456744CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456751CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456768CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
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06931973456850CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
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06931973456935CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
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06931973456966CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456973CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09
06931973456980CaremedShenzhen Caremed Medical Technology Co., Ltd.DXQ2026-07-09